Immunogenicity: Risk & Regulation
Immunogenicity remains a significant challenge in the development and clinical use of biologics and biosimilars. This session provides an in-depth examination of immune response mechanisms triggered by biologic therapies, including anti-drug antibody (ADA) formation and its clinical consequences. Topics include risk factors, detection methods, assay development, and predictive modeling of immunogenicity during preclinical and clinical stages. Regulatory expectations and industry best practices for immunogenicity assessment will be discussed, with an emphasis on guidance from the FDA, EMA, and WHO. The session also reviews mitigation strategies such as protein engineering, formulation optimization, and patient-specific treatment design. Real-world case studies will highlight immunogenicity concerns in therapeutic proteins, monoclonal antibodies, and biosimilar switching. This discussion is crucial for clinicians, regulatory professionals, and drug developers committed to maximizing safety and therapeutic effectiveness in biologic treatments.
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- Regulatory Affairs & Global Approval - Biologics Meet 2026 (UK)
- Regulatory Affairs and Quality Assurance - Drug-Delivery-2026 (France)
- Regulatory Harmonization & Compliance - Biologics Meet 2026 (UK)
- Regulatory Requirements for Pharmaceuticals - PHARMACEUTICAL SCIENCES 2026 (Italy)
- Regulatory Strategies & Quality Control in Biopharma - Biotech-2026 (France)
- Regulatory updates on Biosimilars - Eurobiosimilars 2026 (Italy)
- Regulatory, Quality Control, and Translational Aspects - Drug Devilvery 2026 (France)
- Rehabilitation and Physical Therapy in Pain - Pain Management 2026 (France)
- Risk-Based Monitoring and Trial Optimization - Clinical Trials-2026 (UK)
- Role of Gut Microbiome in Cardiovascular Health - Cardiovascular-2026 (France)
- Role of Inflammation in Cardiovascular Diseases - Cardiovascular-2026 (France)
- Safety Pharmacology - Pharmacology 2026 (Italy)
- Safety Reporting in Early Phase Trials - Clinical Trials-2026 (UK)
- Semi-Solid Dosage Forms - Formulations 2026 (UK)
- Signal Prioritization and Management Techniques - Clinical Trials-2026 (UK)
- Single-Use Technologies in Production - Biologics Meet 2026 (UK)
- Site Management Innovation - Clinical Research 2026 (UK)
- Smart Drug Delivery Systems - Pharmatech 2026 (USA)
- Smart Drug Delivery Systems - PHARMACEUTICA 2026 (UK)
- Smart Drug Delivery Systems - Formulations 2026 (UK)
- Smart Polymers and Biomaterials - Drug-Delivery-2026 (France)
- Solid Dosage Forms - Formulations 2026 (UK)
- Stem Cell and Genetic Clinical Research - Clinical Research 2026 (UK)
- Structure-Based Drug Design and Molecular Docking - Euro MedChem and CADD 2026 (France)
- Sustainable Biologics Manufacturing - Biologics Meet 2026 (UK)
- Synthetic and Green Medicinal Chemistry - Euro MedChem and CADD 2026 (France)
- Synthetic Biology & Bioengineering Approaches - Biotech-2026 (France)
- Target Identification and Validation - Euro MedChem and CADD 2026 (France)
- Targeted Oral and Gastro-Resistant Formulations - Drug Devilvery 2026 (France)
- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2026 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2026 (France)
- The Role of CROs in Clinical Trial Execution - Clinical Trials-2026 (UK)
- Theranostics and Personalized Medicine - Drug Devilvery 2026 (France)
- Toxicology - Pharmacology 2026 (Italy)
- Toxicology & Safety Pharmacology - Euro Pharmacology 2026 (France)
- Track 01: Digital Marketing in Pharma Industry - Future Pharma 2026 (Netherlands)
- Track 02: The Future of Pharma R&D - Future Pharma 2026 (Netherlands)
- Track 03: Pharmaceutical Chemistry - Future Pharma 2026 (Netherlands)
- Track 04: Pharmaceutical Analysis - Future Pharma 2026 (Netherlands)
- Track 05: Pharmaceutics & Pharmacotherapeutics - Future Pharma 2026 (Netherlands)
- Track 06: Industrial Pharmacy and Physical pharmacy - Future Pharma 2026 (Netherlands)
- Track 07: Clinical and Hospital Pharmacy - Future Pharma 2026 (Netherlands)
- Track 08: Pharmaceutical and healthcare Industry - Future Pharma 2026 (Netherlands)
- Track 09: Regulatory Affairs and Intellectual Property Rights - Future Pharma 2026 (Netherlands)
- Track 10: Pharma and Biotech Financial Outlook - Future Pharma 2026 (Netherlands)
- Track 10: Pharmaceutical Engineering - Pharmaceuticalindustry-2025 (Netherlands)
- Track 11: Novel Drug Delivery Systems - Future Pharma 2026 (Netherlands)
- Track 11: Pharmaceutical Supply Chain Optimization - Pharmaceuticalindustry-2025 (Netherlands)
- Track 12: Drug Discovery and Development - Future Pharma 2026 (Netherlands)
- Track 12: Pharmaceutical Regulatory Requirements - Pharmaceuticalindustry-2025 (Netherlands)
- Track 13: Green and Community Pharmacy - Future Pharma 2026 (Netherlands)
- Track 13: Pharmaceutical Packaging Advances - Pharmaceuticalindustry-2025 (Netherlands)
- Track 14: Big data analytics and Pharma - Future Pharma 2026 (Netherlands)
- Track 1: Digital Parma - Pharmaceuticalindustry-2025 (Netherlands)
- Track 2: R&D Progress: The Path to New Medicines - Pharmaceuticalindustry-2025 (Netherlands)
- Track 3: Clinical Pharmacy and Therapeutics - Pharmaceuticalindustry-2025 (Netherlands)
- Track 4: Pharmaceutical sciences - Pharmaceuticalindustry-2025 (Netherlands)
- Track 5: Pharmaceutical Nanotechnology - Pharmaceuticalindustry-2025 (Netherlands)
- Track 6: Entrepreneurs Investment - Pharmaceuticalindustry-2025 (Netherlands)
- Track 7: The Globalized Pharmaceutical Industry - Pharmaceuticalindustry-2025 (Netherlands)
- Track 8: Drug Discovery - Pharmaceuticalindustry-2025 (Netherlands)
- Track 9: Drug Development - Pharmaceuticalindustry-2025 (Netherlands)
- Transdermal and Intradermal Delivery Systems - Drug-Delivery-2026 (France)
- Transdermal and Topical Drug Delivery - Drug Devilvery 2026 (France)
- Translational Research & Clinical Applications - Biotech-2026 (France)
- Types of Formulations - Formulations 2026 (UK)
- USFDA Approved Biosimilars - Eurobiosimilars 2026 (Italy)
- Vaccine Delivery Technologies - Drug-Delivery-2026 (France)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2026 (UK)
- Vaccine Technologies & Immunotherapeutics - PHARMA BIOTECH 2026 (UK)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2026 (France)
- Veterinary & Comparative Pharmacology - Euro Pharmacology 2026 (France)
- Wearable and Implantable Drug Delivery Devices - Drug Devilvery 2026 (France)